Clinical Efficacy of Different Fissure Sealant Materials in the Newly Erupted Non-Carious First Permanent Molars
- Conditions
- Fissure Sealant
- Registration Number
- NCT04854720
- Lead Sponsor
- Izmir Katip Celebi University
- Brief Summary
The aim of this study is to compare the clinical retention rates, marginal adaptation, marginal discoloration and secondary caries formation of two different types of resin-modified glass ionomers (Fuji® II LC; Clinpro™ XT Varnish) and giomer-containing fissure sealant materials (Beautifil Flow) with glass ionomer-containing fissure sealant material (Fuji Triage®) used on newly erupted non-carious first permanent molars as a fissure sealant.
The study included 384 teeth belonging to 182 children, aged between 5 to 9 years old, who have two newly erupted mandibular permanent first molars.
- Detailed Description
Firstly, patients were randomly allocated to three main groups: Group 1; Fuji II LC/Fuji Triage (Control) (62 patients), Group 2; Clinpro XT Varnish/Fuji Triage (Control) (60 patients), Group 3; Beautifil Flow/Fuji Triage (Control) (60 patients). After clinical applications, all samples were evaluated in terms of retention, marginal adaptation, marginal discoloration and secondary caries formation using modified USPHS criteria in 6th, 12th and 18th months. Also samples were evaluated in terms of remineralization effect using the laser fluorescence method. Evaluations on occlusal and buccal surfaces were performed separately.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 182
- Children who have two newly erupted non-carious mandibular permanent first molars that fissure sealant is indicated,
- Newly erupted first permanent molars show scores of 0 (Sound tooth surface)-1(First visual change in enamel) according to ICDAS II,
- Newly erupted first permanent molars show scores between 0-13 by using DIAGNOdent device,
- Children who haven't any systemic disease that prevents the application,
- Cooperative children who allowed the clinical applications.
- Teeth with proximal and initial caries,
- Teeth with applied fissure sealant,
- Teeth with developmental defects such as hypoplasia and restorations,
- Non-cooperative children who don't allow the clinical applications,
- Children and parents who denied the participation in the follow-up appointments.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method The assessment of clinical retention rates of fissure sealants applied to newly erupted permanent first molars. 18 months after the clinical applications The primary outcome of the study was the assessment of clinical retention rates at 18th months.
The assessment of marginal discoloration rates of fissure sealants applied to newly erupted permanent first molars. 18 months after the clinical applications The primary outcome of the study was the assessment of marginal discoloration rates at 18th months.
The assessment of secondary caries rates of fissure sealants applied to newly erupted permanent first molars. 18 months after the clinical applications The primary outcome of the study was the assessment of secondary caries rates at 18th months.
The assessment of marginal adaptation rates of fissure sealants applied to newly erupted permanent first molars. 18 months after the clinical applications The primary outcome of the study was the assessment of marginal adaptation rates at 18th months.
- Secondary Outcome Measures
Name Time Method The assessment of remineralization capacity using DIAGNOdent device 18 months after the clinical applications The secondary outcome of the study was the assessment of remineralization capacity using DIAGNOdent, at 18th months.
Trial Locations
- Locations (1)
Izmir Katip Celebi University
🇹🇷Izmir, Turkey
Izmir Katip Celebi University🇹🇷Izmir, Turkey